Embolectomy in Acute SYlvian Thrombosis in Refractory or Ineligible Patients to ALteplase

Stroke, Acute Clinical Trial

— EASY  

Official title:

Benefits of the Endovascular Treatment in the Early Management of Proximal Sylvian Artery Thrombosis in Patients Refractory or Ineligible to Intravenous Fibrinolysis : a Multicenter Controled Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02216565
• Other study ID #: 2014-A00519-38
• Status: Terminated
• Phase: N/A
• First received: August 13, 2014
• Last updated: December 4, 2017
• Start date: December 1, 2014
• Est. completion date: August 24, 2017

Study information

• Verified date: December 2017
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims at comparing two strategies currently used to address acute ischemic stroke of the middle cerebral artery : medical treatment without endovascular treatment on the one hand, and medical treatment plus endovascular treatment on the other hand. The efficiency of the strategies will be assessed in terms of early neurological clinical recovery.

The study will focus on three particular situations : (1) tandem internal carotid and middle cerebral artery occlusion, (2) situations where patient cannot benefit from fibrinolysis because of high risk of haemorrhage, (3) situations where fibrinolysis is not recommended because of a delay superior to 4.5 hours.

The hypothesis to be tested is that medical approach plus endovascular treatment is superior to medical treatment alone

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 24, 2017
• Est. primary completion date: August 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• Radiologically proven acute proximal occlusion of middle cerebral artery

AND one of the three following :

1. tandem internal carotid / middle cerebral artery occlusion

2. intravenous thrombolysis contraindicated because of high risk of haemorrhage

3. intravenous thrombolysis not possible because of delay > 4.5 hours

Exclusion Criteria:

• Impossibility to perform endovascular recanalization within 6h

• Clinically minor stroke (NIHSS score below 5 at baseline)

• Extended cerebral infarction

• Severe comorbidity

• Life expectancy below 3 months before stroke

• Pregnancy or breastfeeding

• modified Rankin Score superior to 2 before stroke

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute
• Thrombosis

Intervention

Other:
• Hospitalization in specialized neuro-vascular unit

Drug:
• Alteplase if patient is eligible
Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)

Other:
• Supportive care
Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition

Procedure:
• Endovascular treatment
Recanalization treatment (thrombectomy / intraarterial thrombolysis)

Locations

Country	Name	City	State
France	Hopital Henri Mondor	Creteil
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in NIHSS score after 24h	Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and h24 (t1) calculated as follow : [NIHSS(t0) - NIHSS(t1)] / NIHSS(t0)	24 hours
Secondary	Improvement in NIHSS score after 7 days	Percentage of improvement in the National Institute of Health Stroke Score (NIHSS) between baseline (t0) and day7 (t2) calculated as follow : [NIHSS(t0) - NIHSS(t2)] / NIHSS(t0)	7 days
Secondary	Functional recovery after 3 months	modified Rankin Score (mRS) after 3 months ("positive recovery" if mRS <=2, "excellent recovery" if mRS<=1)	3 months
Secondary	Fatality within 7 days	Proportion of patients deceased within seven days after stroke	7 days
Secondary	Fatality within 3 months	Proportion of patients deceased within 3 months after stroke	3 months